By David C. HolzmanWashington Editor
WASHINGTON -- President Clinton's failure to include aninterpretive statement when he signed the Biodiversity Treatyin June has unnerved the biotechnology industry.
The pact is ambiguous on issues that could affect internationaltrade in products derived from biotechnology. An interpretivestatement, which the Biotechnology Industry Organization (BIO)helped the Clinton administration develop, would have clarifiedthose issues.
The statement could still be attached to the treaty prior toratification, which could happen sometime later this fall.However, BIO has been anxious enough to lobby theadministration; BIO President Carl Feldbaum stated theindustry's case in a letter to Vice President Gore last month.
Without the interpretive statement, Feldbaum wrote, less-developed countries could expropriate companies' intellectualproperty rights. Furthermore, as a state department officialexplained to BioWorld, Third World countries have beenpushing for a so-called safety protocol throughout thebiodiversity negotiations. This could allow them to invokepotential ravages from engineered organisms to close theirborders to foreign fruits of biotechnology.
Meanwhile, in Europe, the International Bioindustry Forum hasjust addressed both concerns in a "statement of principle" notyet released in the U.S., and on Sept. 24, representatives ofdeveloped countries met in Geneva to work on an interpretivestatement.
"They are all going back to their respective governments tosupport that effort," Bruce Lehman, commissioner of the U.S.Office of Patents and Trademarks, who was in Geneva, toldBioWorld.
On the issue of protecting intellectual property, theInternational Bioindustry Forum said, "Interpretivestatements...will be necessary in particular to ensure adequateprotection of intellectual property rights..." and should "(clarify)that transfer of technology can only be done on a voluntarybasis based on market principles."
Some observers fear that an ambiguous biodiversity agreementmight undermine the not-yet-signed Trade Related IntellectualProperty Rights (TRIPS) agreement of the General Agreementon Trade and Tariffs (GATT), which President Clinton hasannounced he wants to sign on Dec. 15.
"There is no direct linkage (between the two treaties), but somecountries are going to try to interpret the (biodiversity)convention in order to lower the degree of protection in theTRIPS agreement," a source within the European Communitytold BioWorld.
As for safety, Brian Ager, director of the Senior Advisory GroupBiotechnology (SAGB), in Brussels, the European tradeassociation, fears that some countries might try to adoptobsolete European regulations on safety just as the EuropeanCommission is getting ready to toss them out.
Europe regulates process rather than product, which means, forexample, that approval of biotechnology-derived drugs, bugsand crops requires reams of data compared with approval ofconventional drugs. This hampers trade.
On Sept. 24, representatives of industry, trade unions andacademia met with the president of the European Communityin Brussels at a round table organized by the Belgiangovernment and SAGB. "The key priority agreed upon at thatmeeting was the need to amend the regulatory approach thathas been adopted in Europe," Ager told BioWorld.
PTO Commissioner Lehman, who received a copy of Feldbaum'sletter to Gore, protested safety-related trade barriers to U.S.biotechnology products. "The U.S. has the highest health andsafety standards in the world, and if you can market it here, Ican't imagine not being able to market it elsewhere."
In his letter, Feldbaum requested that BIO be allowed toreview the treaty and the interpretive statement. None ofseveral administration sources queried could tell BioWorldwhether Feldbaum's request would be honored.
However, Lehman said categorically to BioWorld, "There isgoing to be an interpretive statement."
(c) 1997 American Health Consultants. All rights reserved.